55488 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

801(e)(2) 25 1 25 2.5 62.5 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden estimates are based on the 

experience of FDA’s medical device 

program personnel. 

Dated: September 15, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8026 Filed 9–21–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0381] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Mammography 

Quality Standards Act Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the estimated reporting and 

recordkeeping burden associated with 

the Mammography Quality Standards 

Act requirements. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 21, 2006. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1472. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

The Mammography Quality Standards 

Act Requirements—21 CFR Part 900 

(OMB Control Number 0910–0309)—

Extension 

The Mammography Quality Standards 

Act requires the establishment of a 

Federal certification and inspection 

program for mammography facilities; 

regulations and standards for 

accreditation and certification bodies for 

mammography facilities, and standards 

for mammography equipment, 

personnel, and practices, including 

quality assurance. The intent of these 

regulations is to assure safe, reliable, 

and accurate mammography on a 

nationwide level. 

Under the regulations, as a first step 

in becoming certified, mammography 

facilities must become accredited by an 

FDA approved accreditation body. This 

requires undergoing a review of their 

clinical images and providing the 

accreditation body with information 

showing that they meet the equipment, 

personnel, quality assurance and quality 

control standards, and have a medical 

reporting and recordkeeping program, a 

medical outcomes audit program, and a 

consumer compliant mechanism. On the 

basis of this accreditation, facilities are 

then certified by FDA or an FDAapproved State certification agency and 

must prominently display their 

certificate. These actions are taken to 

ensure safe, accurate, and reliable 

mammography on a nationwide basis. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/ 

FDA Form 

No. of 

Respondents 

Annual 

Frequency 

perResponse 

Total Annual 

Records 

Hours per 

Response Total Hours Total Capital Costs 

Total Operating & 

Maintenance Costs 

900.3(b)(1) 0.33 1 0.33 1 0.33 

900.3(b)(3) full1 0.33 1 0.33 320 106 $10,000 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 55489 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section/ 

FDA Form 

No. of 

Respondents 

Annual 

Frequency 

perResponse 

Total Annual 

Records 

Hours per 

Response Total Hours Total Capital Costs 

Total Operating & 

Maintenance Costs 

900.3(b)(3) limited2 5 1 5 30 150 

900.3(d)(2) 0.1 1 0.1 30 3 

900.3(d)(5) 0.1 1 0.1 30 3 

900.3(e) 0.1 1 0.1 1 0.1 

900.3(f)(2) 0.1 1 0.1 200 20 $36 

900.4(c) facility3 2,947 1 2,947 10.54 4,538 

900.4(c) AB4 6 1 6 378 2,268 $117,867 

900.4(d) facility3 2,947 1 2,947 0.77 2,947 

900.4(d) AB4 6 1 6 189 1,134 

900.4(e) facility3 8,840 1 8,840 1 8,840 $8,840 

900.4(e) AB4 6 1 6 1,473 8,838 

900.4(f) 336 1 336 7 2,352 $77,840 

900.4(h) facility3 8,840 1 8,840 1 8,840 $3,536 

900.4(h) AB4 6 1 6 10 60 

900.4(i)(2) 1 1 1 16 16 

900.6(c)(1) 0.1 1 0.1 60 6 

900.11(b)(3) 5 1 5 0.5 2.5 

900.11(c) 270 1 270 5 1,350 

900.12(c)(2) 8,840 4,072 36,000,000 0.083 3,000,000 $14,400,0005

900.12(c)(2) patient refusal5 89 1 89 0.5 44.5 

900.12(h)(4) 5 1 5 1 5 

900.12(j)(1) facility3 25 1 25 200 5,000 $250 

900.12(j)(1) AB4 25 1 25 1,000 25,000 $750 

900.12(j)(2) 3 1 3 100 300 $3,604 

900.15(c) 5 1 5 2 10 

900.15(d)(3)(ii) 1 1 1 2 2 

900.18(c) 2 1 2 2 4 

900.18(e) 2 1 2 1 2 

900.21(b) 1 1 320 320 2 $30,000 $71 

900.21(c)(2) 0.33 1 0.33 30 10 

900.22(h) 6 200 1,200 0.083 100 

900.22(i) 2 1 2 30 60 

900.23 6 1 6 20 120 

900.24(a) 0.3 1 0.3 200 60 $26 

900.24(a)(2) 0.15 1 0.15 100 15 $13 


sroberts on PROD1PC70 with NOTICES
55490 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section/ 

FDA Form 

No. of 

Respondents 

Annual 

Frequency 

perResponse 

Total Annual 

Records 

Hours per 

Response Total Hours Total Capital Costs 

Total Operating & 

Maintenance Costs 

900.24(b) 1.2 1 1.2 30 36 

900.24(b)(1) 0.3 1 0.3 200 60 $26 

900.24(b)(3) 0.15 1 0.15 100 15 $13 

900.25(a) 0.2 1 0.2 16 3.2 

FDA Form 3422 700 1 700 0.25 175 

Total 3,072,138 $40,000 $14,612,872 

1 Refers to entities that are applying for the first time. 

2 Refers to accreditation bodies applying to accredit specific Full Field Digital Mammography units. 

3 Refers to the facility component of the burden for this requirement. 

4 Refers to the accreditation body component of the burden for this requirement. 

5 Refers to the situation where a patient specifically does not want to receive the lay summary of her exam. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

CFR Section Number of 

Recordkeepers 

Annual 

Frequency of 

Recordkeeping 

Total Annual 

Records 

Hours per 

Recordkeeper 

Total 

Hours 

Total Capital 

Costs 

Total Operating & 

Maintenance 

Costs 

900.4(g) 6 1 6 1 6 

900.12(a)(1)(i)(B)(2) 89 1 89 8 712 

900.12(a)(4) 8,840 4 35,360 1 35,360 

900.12(c)(4) 8,840 1 8,840 1 8,840 $25,000 

900.12(e)(13) 8,840 52 459,680 0.083 38,154 

900.12(f) 8,840 1 8,840 16 141,440 

900.12(h)(2) 8,840 2 17,680 1 17,680 

900.22(a) 6 1 6 1 6 

900.22(d) 6 1 6 1 6 

900.22(e) 6 1 6 1 6 

900.22(f) 3 1 3 1 3 

900.22(g) 6 1 6 1 6 $60 

900.25(b) 6 1 6 1 6 

Total 242,225 $25,000 $60 

This request for OMB approval now 

serves to consolidate previously 

approved information collection, OMB 

Control Number 0910–0580 into 0910–

0309. The hourly burden as well as the 

associated operating costs were 

increased to better represent the actual 

burden and costs on facilities and 

accreditation bodies. 

The following regulations were not 

included in the above burden tables 

because they were considered usual and 

customary practice and were part of the 

standard of care prior to the 

implementation of the regulations. 

Therefore, they resulted in no additional 

reporting or recordkeeping burden: 21 

CFR 900.12(c)(1), 900.12(c)(3), and 

900.3(f)(1). 

The following regulations were not 

included in the previously mentioned 

burden tables because they were not 

considered applicable during the 

information collection period or their 

burdens were reported under other 

regulatory requirements. Therefore, they 

resulted in no additional reporting or 

recordkeeping burden: 21 CFR 900.3(c), 

900.11(b)(1), 900.11(b)(2), and 900.24(c). 

Dated: September 15, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8027 Filed 9–21–06; 8:45 am] 

BILLING CODE 4160–01–S 


sroberts on PROD1PC70 with NOTICES